Homedics

GUDID 00198715239751

TENS & EMS pain therapy device

Shenzhen Yiran Intelligence Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00198715239751
• NIH Device Record Key: 0d418554-c0f7-408e-bd9a-9fff003e1a67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Homedics
• Version Model Number: TENS-160J
• Company DUNS: 707408239
• Company Name: Shenzhen Yiran Intelligence Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198715239751 [Primary]

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-28
• Device Publish Date: 2025-01-20

Devices Manufactured by Shenzhen Yiran Intelligence Co., Ltd.

• 00198715239751 - Homedics: 2025-01-28TENS & EMS pain therapy device
• 00198715239751 - Homedics: 2025-01-28 TENS & EMS pain therapy device
• 00198715084832 - Muscle stimulator: 2024-09-23
• 00198715187830 - Muscle Stimulator: 2024-09-23
• 00198715286663 - Muscle Stimulator: 2024-09-23
• 00198715837629 - Muscle Stimulator: 2024-09-23